WELCOME

ETHICS IN RESEARCH

PRESENTED BY

JIYA G PANTHANALIL

IST YEAR MSC NURSING

NIMHANS, BANGALORE

INTRODUCTION

• Research contributes to nursing knowledge

• Research influence patient care standards

• Professional nurses are obliged to ensure safe, robust and ethical research

DEFINITION

• ETHICS-Greek word: ethos=custom or convention, or the spirit of community

• Moral principles that govern a person’s behaviour or the conducting of an activity: Oxford dictionary (2014)

• The branch of philosophy that deals with morality. Ethics is concerned with distinguishing between good and evil in the world, between right and wrong human actions, and between virtuous and non virtuous characteristics of people-The American Dictionary of Cultural Literacy (2005)

• Nursing ethics is defined as the principles of proper professional conduct concerning the rights and duties of nurses themselves, their patients, and their fellow practitioners, as well as their actions in the care of patients and in relations with their families- U S National Library of Medicine (2014)

WHAT ETHICS IS AND WHAT IT IS NOT

WHAT ETHICS IS • About commitment to

positive values

• A communal activity, applying rational principles and universal standards to social life

• About real power relations and responsible power sharing

WHAT ETHICS IS NOT• About negative code of

conduct, moral prohibitions, disciplinary rules

• A private matter, nor about subjective feelings, personal attitudes and choices

• Introspective self examination, or judging one’s or other’s moral state

WHAT ETHICS IS• About active participation

in a moral community

• Problem solving activity

• An educational process

WHAT ETHICS IS NOT• Personal reliance on

experts, lawyers, philosophers or religious authorities

• Interminable disputes, or insoluble dilemma

• Occult processes

ETHICAL THEORIES

• Deontology- duty is the basis of all action

• Teleology- actions can only judged on the basis of consequences they produce

Utilitarianism-central concern is ‘the general welfare rather than individual’s interest’

HISTORICAL EVENTS AND DEVELOPMENT OF CODE OF ETHICS

NAZI MEDICAL EXPERIMENTS (1933-1945)

• Atrocious, unethical activities implemented in Third Reich in Europe from 1933-1945

• Programs included sterilisation, euthanasia, and numerous medical experiments in Nazi concentration camps

• Sterilised Jews whom Nazis considered as racial enemies

• Medical experiments involved exposing to high altitudes, freezing temperature, malaria, poisons, typhus fever, untested drugs and surgery without anaesthesia

• Selection of subjects was racially based

• Subjects had no opportunity to refuse the participation

NUREMBERG CODE- 1949

Mistreatment of human subjects in Nazi experiments led to the development of Nuremberg Code (1949)

Nuremberg Code contains guidelines for• Voluntary consent• Withdrawal of subjects from study• Protection of subjects from physical and mental

suffering, injury, disability, and death• The balance of benefits and risks in the study

DECLARATION OF HELSINKI (1964)

• Greater care can be exercised to protect subjects from harm

• Strong, independent justification for exposing a healthy volunteer to substantial risk of harm

• Investigators must protect life and health of research subjects

TUSKEGEE SYPHILIS STUDY(1932)

• U S Public Health Service initiated the study in town of Tuskegee, Alabama

• Research subjects were divided into two groups

• One group of 400 men who had untreated syphilis

• Control group of 200 men without syphilis

WILLOWBROOK STUDY (1950-1970)

• Research on hepatitis by Dr. Krugman at Willowbrook among mentally retarded children

• Early subjects were fed extracts of stool from infected individuals

• Later subjects received injections of purified virus

• Parents were forced to give permission for the child to be a subject

JEWISH CHRONIC DISEASE HOSPITAL STUDY (1960)

• Study conducted to determine patients’ rejection responses to live cancer cells

• Twenty two patients were injected with a suspension containing live cancer cells

• Physician from Sloan-Kettering Institute for cancer research directed the study

• Study conducted without the informed consent

IMPORTANCE OF ETHICS IN RESEARCH

• Protects the vulnerable group and other study participants

• Participants are safeguarded from exploitation• Establishes risk-benefit ratio for study subjects• Ensures fullest respect, dignity, privacy,

disclosure and fair treatment for subject• Builds capability of subjects to accept or reject

participation in study

ETHICAL PRINCIPLES

The Belmont report articulates three primary ethical principles

Beneficence

Respect for human dignity

Justice

BENEFICENCE• Imposes duty on researchers to

minimise harm and to maximise benefits

The right to protect from harm and discomfort

Freedom from exploitationBenefits from research

RISK BENEFIT RATIO

MAJOR POTENTIAL BENEFITS TO PARTICIPANTS

MAJOR POTENTIAL RISKS TO PARTICIPANTS

•Access to an intervention that otherwise be unavailable to them•Comfort to discuss situation with a friendly person•Increased knowledge of themselves•Satisfaction in helping others•Monetary or material gains

•Physical harm•Boredom ,fatigue,physical discomfort•Psychological or emotional discomfort•Social risks •Loss of privacy•Loss of time•Monetary costs

THE PRINCIPLE OF RESPECT FOR HUMAN DIGNITY

• The right to self determination-Humans should be treated as autonomous agents, capable of controlling their own activities

• The right to full disclosure-Researcher should fully describe the nature of study, subject’s right to refuse participation, researcher’s responsibility and risks and benefits

ISSUES RELATED TO PRINCIPLE OF RESPECT

• Inability of individuals to make well informed judgements

• Bias• Concealment• Deception

THE PRINCIPLE OF JUSTICE

• The right to fair treatment

• The right to privacy

INFORMED CONSENT

INFORMED CONSENT

• Participants have adequate knowledge regarding research, have the power of choice, enabling to decline participation voluntarily.

• Informed assent-the process where by minors may agree to participate in clinical trials.

VULNERABLE SUBJECTS

THERAPEUTIC MISCONCEPTION

• Research subject misinterpret and enrol in the study thinking it to be routine medical care

• Misinterpret the information and believes that research directly benefits him

POST TRIAL ACCESS

• Holds special importance for clinical research

• Pharmaceutical companies from developed countries collect data from developing countries

• Most of these drugs would never be used by the communities from where the experimental data is collected

ETHICAL DILEMMAS

CODE OF ETHICS FOR DIFFERENT DISCIPLINES

1978

• Important Code of ethics adopted by National Commission for the Protection of Human Subjects of Biomedical and Behavioural Research (U. S)

1992

• Guidelines for psychologists published by the American Psychological Association in Ethical principles of Psychologists and Code of Conduct

1995

• The American Nurses’ Association put forth a document entitled Ethical guidelines in the Conduct, Dissemination and Implementation of Nursing Research

CODE OF ETHICS FOR NURSES IN INDIA

INSTITUTIONAL REVIEW/INSTITUTIONAL ETHICAL

COMMITTEE• Committee that reviews research to ensure

that the investigator is conducting research ethically

• Consists of at least five members from different background

• IRB in hospitals composed of physicians, lawyers, clergy, community and lay persons and more recently nurses

LEVELS OF REVIEW BY IRB

• Exempt from interview

• Expedited interview

• Complete review

RESEARCH MISCONDUCT

FABRICATION

FALSIFICATION

PLAGIARISM

RESEARCH MISCONDUCT

PLAGIARISM CHECKER

ROLE OF PEER REVIEWERS, JOURNAL EDITORS, AND RESEARCHERS

• Fraudulent- If there is documentation or testimony from co-authors that publication didnot reflect what had actually been done

• Questionable- If no co-author could produce the original data or had personally observed or performed or participated in research publication

GUIDELINES FOR CRITIQUING ETHICAL ASPECTS OF STUDY

• Was the study approved and monitored by IRB?

• Were participants subjected to any physical harm or psychological distress?

• Did the benefits outweigh potential risks?

• Was any type of coercion or undue influence used to recruit participants?

• Were the participants deceived in any way?

• Were appropriate informed consent procedures used?

• Were adequate steps taken to safeguard participant’s privacy?

• Were vulnerable groups involved in research?

• Were groups omitted from the inquiry without a justifiable rationale?

ETHICAL CONCERNS IN QUALITATIVE RESEARCH

• Distress

• Misinterpretation

• Identification

• Inconvenience

• ETHICAL CONCERNS IN QUANTITATIVE RESEARCH

Related to the stage of research

• Formulating the research questions

• Designing the study• Collecting data• Analysis• Reporting

ETHICAL CONCERNS IN MIXED METHOD RESEARCH

• Identify and describe issues related to the protection of human subjects

• Understand the ethical issues associated with quantitative and qualitative research

• Be prepared to educate IRB reviewers about mixed method research

ETHICS IN RESEARCH-INDIAN SCENARIO

Twelve general principles are-• Principle of essentiality• Principles of voluntariness, informed consent,

and community agreement• Principle of non-exploitation• Principle of privacy and confidentiality• Principle of precaution and risk minimisation• Principle of professional competence

• Principle of accountability and transparency

• Principle of the maximisation of public interest and of distributive justice

• Principle of institutional arrangements• Principle of public domain• Principle of totality of responsibility• Principle of compliance

ETHICS IN NURSING RESEARCH –INDIAN SCENARIO

• TYPES OF UNETHICAL PUBLICATIONSPlagiarismAuthorship irregularitiesPublication irregularitiesScientific fraud• ETHICAL ISSUES IN USING ANIMALS

IN RESEARCH

STUDENTS’ ROLE IN ETHICS IN RESEARCH

• Ethical clearance should be get done

• Need to get approval from guides and co-guides

• Unethical to publish including guide as co-author

INTERNET ETHICS

• Development of internet over years led to use of internet based research.

• Numerous approaches include web page content analysis, online focus groups, online interviews, analysis of e-conversations

CONCLUSION• If research is based on

a robust design and in a safe and ethical manner, it can be of benefit to all

• Professional codes, laws, regulations, and ethics committees can provide guidance but ultimate determinant rests with researcher’s value system and moral code

DISCUSSION